阿达木单抗药品不良反应文献分析  

Literature Analysis of Adverse Drug Reactions Induced by Adalimumab

作　　者：张裴[1] 许良[1] 李晓雨 沈静[1,2] ZHANG Pei;XU Liang;LI Xiaoyu;SHEN Jing(The Fifth Affiliated Hospital of Xinjiang Medical University,Urumqi,Xinjiang,China 830011;The First Affiliated Hospital of Xinjiang Medical University·Xinjiang Key Laboratory of Clinical Drug Research,Urumqi,Xinjiang,China 830011)

机构地区：[1]新疆医科大学第五附属医院,新疆乌鲁木齐830011 [2]新疆医科大学第一附属医院·新疆药物临床研究重点实验室,新疆乌鲁木齐830011

出　　处：《中国药业》2024年第14期124-128,I0001,共6页China Pharmaceuticals

基　　金：新疆维吾尔自治区药学会科研基金项目[YXH202210]。

摘　　要：目的 为临床合理使用阿达木单抗提供参考。方法 检索中国知网(CNKI)、万方(WanFang)、维普(VIP)、PubMed数据库,获得以阿达木单抗为首要怀疑药物的中英文文献。检索时限为各数据库自建库起至2022年12月。收集患者的基本信息及阿达木单抗药品不良反应(ADR)相关信息,进行分类统计与分析。结果 共检索到文献283篇,筛选后得相关文献101篇,涉及患者101例。其中男56例(55.45%),女45例(44.55%);年龄8~82岁,平均(45.39±17.32)岁,以> 40~60岁居多(47例);来自美国的患者最多(16例),我国与英国并列第4(9例);原患疾病以克罗恩病居多(22例,21.78%);主要累及皮肤及其附件(40例,39.60%),最多见的临床表现为药疹(14例,13.86%);ADR严重程度以中度最多(64例,63.37%);关联性评价结果以很可能最多(79例,78.22%);联合用药21例(20.79%),包括二联用药18例,三联用药2例,四联用药1例;疗程以8周最多见;73例经停药和(或)药物治疗(包括对症支持治疗、换药或改变用药剂量等)后症状治愈或好转,但仍有2例经上述处理后死亡。结论 临床医师在应用阿达木单抗时应准确把握用药指征,严格按药品说明书用药,并熟悉其ADR常见类型和发生时间,加强ADR监测,确保用药安全。Objective To provide a reference for the rational use of adalimumab in clinical practice.Methods The Chinese and English studies with adalimumab as the primary suspected drug in the CNKI,WanFang,VIP and PubMed from the inception of each database to December 2022 were searched.The patients′basic information and adverse drug reactions(ADRs)induced by adalimumab were collected,classified and analyzed.Results A total of 283 studies were searched,and 101 were obtained after screening,involving 101 patients.Among them,there were 56 males(55.45%)and 45 females(44.55%),aged from eight to 82 years,with an average of(45.39±17.32)years,mainly>40 to 60 years(47 cases).The number of patients from the United States was the highest(16 cases),while that from China and the United Kingdom was tied for the fourth(nine cases).The patients′primary disease was mainly Crohn′s disease(22 cases,21.78%).The ADRs mainly affecting the skin and its appendages(40 cases,39.60%),and the most common clinical manifestation was drug eruption(14 cases,13.86%).Most ADRs were graded as moderate(64 cases,63.37%).Most ADRs were probably associated with adalimuma(79 cases,78.22%).There were 21 cases of combined medication(20.79%),including 18 cases of dual medication,two cases of triple medication and one case of quadruple medication.The most common medication course was eight weeks.A total of 73 patients was cured and improved after drug withdrawal and(or)medication treatment(including symptomatic supportive treatment,changing drug or dosage,etc.),while two patients still died after the above treatment.Conclusion Clinicians should accurately know the medication indications when using adalimumab,strictly follow the drug instructions,be familiar with the common types and occurrence time of ADRs,strengthen the ADR monitoring to ensure the medication safety.

关 键 词：阿达木单抗 药品不良反应 文献分析 用药安全 药学监护 

分 类 号：R969.3[医药卫生—药理学]